Herpes Zoster
Conditions
Interventions
Control Group:Placebo for Transfer Factor Oral Solution
Test Group:Valacyclovir Tablets + Transfer Factor Oral Solution
Sponsors
Dermatology Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 to 75 years old (inclusive of 18 and 75 years old), with no restriction on gender ratio; 2.Participants fully understand the purpose, nature, methodology of the study and the possible adverse reactions, voluntarily agree to participate as subjects, and sign the informed consent form before the study begins; 3.Female participants of childbearing age (and their male partners) as well as male participants (and their female partners) must use highly effective contraceptive measures throughout the entire study period and for at least 3 months after the last dose of medication. Participants must have no plans for pregnancy, sperm donation, or egg donation throughout the entire study period and for at least 3 months after the last dose of medication. 4.Patients clinically diagnosed with herpes zoster in accordance with the Chinese Expert Consensus on Herpes Zoster (2022 Edition); 5.Patients can be enrolled in the study within 3 days (72 hours) after the onset of skin rashes; 6.Pain Visual Analog Scale (VAS) score >= 3;
Exclusion criteria
Exclusion criteria: 1.Participants with clinically significant abnormalities in the results of various screening examinations (including physical examination, vital signs, complete blood count, urine routine, blood biochemistry, 12-lead electrocardiogram, etc.), and who are deemed unsuitable for enrollment by the investigator; 2.Participants with clinically significant abnormalities indicated by virological screening tests (including hepatitis B surface antigen [HBsAg], hepatitis C antibody [anti-HCV], and human immunodeficiency virus [HIV] testing); 3.A history of severe primary diseases involving major organs, including but not limited to diseases of the gastrointestinal tract, respiratory system, kidneys, liver, nervous system, hematological system, endocrine system, as well as tumors, immune system disorders, mental illnesses, or cardiovascular and cerebrovascular diseases; 4.Participants who have undergone trauma, gastrointestinal surgery, or other major surgical procedures within 4 weeks prior to screening, or who plan to undergo surgery during the study period; 5.Participants who are allergic to two or more drugs or foods (such as milk and pollen), or who have a known allergy to the components of the study drug(s) or their analogs; 6.Participants who have participated in other clinical trials and received investigational drugs or medical devices within 3 months prior to screening, with the date of the last administration of the investigational drug or use of the investigational medical device as the time reference; 7.Participants who have received any vaccine within 3 months prior to screening or plan to receive any vaccine during the study period; 8.Other circumstances deemed unsuitable for enrollment by the investigator; 9.Participants with clinically diagnosed special types of herpes zoster, such as herpes zoster oticus, herpes zoster ophthalmicus, abortive or zoster sine herpete (zoster without rash), herpes zoster complicated with viral encephalitis or meningitis, herpes zoster complicated with acute gastroenteritis or cystitis, disseminated herpes zoster, and herpes zoster presenting with clinical manifestations of hemorrhage or gangrene; 10.Participants with neuralgia at the herpes site caused by other diseases; 11.Participants who have systemically used drugs effective for herpes zoster (including interferons, antiviral drugs, immunomodulators, glucocorticoids, traditional Chinese medicines/preparations, neurotrophic drugs, theophylline-containing drugs, etc.) within 1 month prior to screening or within 5 half-lives of the drug (whichever is longer); 12.Participants who have received local drug treatment for herpes zoster within 2 weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Relief of Herpes Zoster Symptoms and Signs (Time to Blister Cessation, Crusting, Decrustation, and Pain Relief); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in VAS score relative to baseline at days 7, 14, 21, and 28 post-administration;Occurrence of AE/ADR and SAE/SAR;Time to achieve a VAS score <=2;Number of analgesic doses taken; | — |
Countries
China
Contacts
Public ContactLi Huizhong
Dermatology Hospital, Southern Medical University
Outcome results
None listed